Medical male luer connectors have been standardized through ISO standard ISO-594-1 and 594-2. The geometry and use has been relatively unchanged for many years. However, the advent of communicable diseases transmittable by needle-sticks has driven multiple advancements on the female side of luer connectors. Injection sites and standard female luers have in many cases been replaced with “needle-free connectors”—i.e. female luers with an integrated valve. The valve is opened when a male luer is inserted into the device. When the male luer is removed, the valve closes. The needleless-device adaptation in healthcare continues to be driven by the need to reduce the number of needle sticks, and was accelerated by needle stick prevention legislation. Other benefits to needleless devices include reduction or total elimination of sharp components and systems that auto-close, keeping fluid path sterility in check.
Typical luer connections utilize a male luer connector that is inserted into a female luer connector. The male luer connector is typically threaded onto corresponding threads of the female luer connector to engage the two devices so that fluid may be passed between them without escaping or leaking from the connection.
Male luer components are adapted for use with multiple devices and procedures—such as chemotherapy, blood transfusion, and nuclear medicine. During these procedures with conventional luer devices, exposure to fluids—cytotoxic drugs, blood borne pathogens, radioactive drugs—may occur and result in serious consequences for the patient, caregiver, housekeeping staff, or any other individual who may come in contact with the fluids. Currently available male luer connectors when removed or inadvertently dislodged from its female connection may introduce substances to the atmosphere, leaking the drug or blood contents, and thereby exposing those individuals to the potentially harmful contents. The current process for removing a male luer from its fluidic system connection is to first clamp and then remove (as with an IV set), or just remove with extreme caution as to not drip or spill the fluid. This process is not automatic, leaves room for human error, and does not address the potential drops at the tip of the male luer even if the clamp is successfully used. Additionally, even if the fluid does not leak when the connectors are disengaged, the residual amount of fluid remaining on the tip of the connectors may still be harmful.
Previously described valved male luer connectors require an internal post that is provided by a specific type of valved female luer (such as the ICU Medical Clave needle-free valve) to protrude into the valved male luer. This greatly limits the ability for the device to work with multiple female luer and needle-free valves that are commercially in use.
The previously described male luer connectors may also require multiple valve components that are inserted inside the male body of the connector, thus complicating the manufacturing process due to space constraints within the male luer tip, and may limit the flow rate of the connector below that of the flow rate of a typical male luer.
Some previously described valved male connectors utilize metal springs that may make x-ray and MRI images unclear, and the stored kinetic energy of the spring may drive the valve component internal to the male luer toward the tip of the male luer and expel a small droplet or mist of fluid out of the tip upon disconnection.
Other previously described valved male connections include internal valve components downstream of the tip of the male connection just beyond its base. While flow rate through these devices may be acceptable, the tip of the male connector is left exposed to the environment, keeping the patients and clinicians at risk of exposure to droplets or mists that may easily be expelled from within the void volume of the male connector tip itself. These designs also suffer from having multiple components, adding complexity and cost to assembly, and may contain metal springs that may make x-ray and MRI images unclear. Additionally, these designs are not swab-able.
Other previously described self-sealing male connectors may be limited in their compatibility with existing needle-free valves on the market. For example, some valved male luer connector designs may be compatible with some female valves (such as SmartSite) with no internal protruding post. However, use with female connectors with internal posts would geometrically prohibit the insertion of the internal posts into smaller diameter holes of the male tip, likely resulting in damage to one or both of the devices, potentially rendering either unusable. In addition, the post within some of the previously described self-sealing male connector designs protrudes through the elastic member, causing a “squeegee effect” on the internal post of the device, leaving potentially harmful fluid droplets on the tip upon its disconnection.
Additionally, other previously described self-sealing male luer connectors with biased valve plugs would be inherently unattractive in both their incompatibility with some needle-free valves on the market and in their low flow rates through the device. These devices would not be compatible with many needle-free valves having internal posts (such as the ICU Medical Clave needle-free valve) as the post would be geometrically prohibited from insertion into the ID of the male connector tip. This would likely damage one or both devices, perhaps rendering one or the other unusable.
By redesigning the standard male luer connector to be a valved male connector capable of completely shutting off flow at the tip of the male connector with no restrictions within the male luer itself, the problems listed above may be avoided. Additionally, if the male luer connector may be adequately disinfected by swabbing prior to connecting or between connections, it may eliminate any need for a cap to be used—an extra component that adds cost and often becomes lost. Finally, by automatically shutting off upon disconnection, the underlying fluid path sterility may be more readily maintained, whereas it would otherwise be exposed to the environment.
Therefore, disclosed herein is a more universally compatible valved male connector that securely contains the fluid materials included therein when engaged to a standard female luer or needless connector. There is also disclosed a valved male connection that, when disengaged, seals off the male connector so that users of the connector are protected from hazardous drugs that might otherwise remain on, or just inside, the connector tip surface.